FDA Consulting for US Market Access
Achieving Full Compliance in the United States
Qserve is a leading consulting firm offering medical device and in vitro diagnostic regulatory and quality management services. We specialize in helping clients achieve and maintain market access in the United States and around the world. Our team of experienced regulatory and quality experts
have a deep understanding of the regulatory landscape and can help manufacturers navigate the complex requirements for medical device and IVD US market access. Whether you need help with gap analysis
, risk management
, clinical evaluation
, or post-market surveillance, Qserve uses a practical approach to support you every step of the way. With a commitment to quality, Qserve is your ideal partner when looking to enter or expand your presence in the US market.
Determining the Right Route to US Market Access
Medical devices and IVDs are classified into three classes by the FDA: class I being the lowest risk and class III the highest risk (details on classification 21 CFR, parts 800-1107). The low-risk medical devices are known as class I and are exempt from FDA review. Medium-risk devices require 510(k) pre-market notification to be sold in the US, while high-risk devices must go through the premarket approval (PMA) application under section 515 of the FD&C Act to obtain market access.
Our team of Qserve experts can help you in every stage of developing your market access strategy.
Qserve can help you navigate the complex regulatory landscape for medical devices and IVDs in the United States. Our team of experienced professionals have extensive knowledge and experience in working with the FDA and will work closely with you to develop a strategic plan for US market access.
- Regulatory strategy
- Due diligence
- Auditing (manufacturer quality management system, suppliers)
- Gap analysis (quality management system, design history file)
- Training (QSR, GMP)
Qserve is a leading provider of product development services for companies looking to enter the US market. We work closely with our clients to understand their medical device or IVD to create a regulatory plan to meets their specific needs.
- Regulatory plan
- Quality plan
- Design & development plan
- Risk management
- Software development planning and documentation
- Cybersecurity and interoperability assessment and reports
- Equipment safety and electromagnetic compatibility (determine applicable standards and assist with design elements)
- Master validation plan (manufacturing)
- Supplier qualification
- Supplier quality agreements
- Quality management system (policies, procedures, audits; FDA QSR/GMP, MDSAP, ISO 13485)
Qserve can assist with product verification to ensure your medical device meets the standards set by the FDA. We can guide you through the process of verifying your product to meet FDA clearance.
- Design analytical studies
- Study protocols
- Study data analysis
- Study reports
- Usability studies (formative)
- Manufacturing process validation
- Investigational device exemptions (IDE)
- Significant risk determinations (SRD)
Qserve provides comprehensive commercialization support for medical devices and IVDs and is dedicated to ensuring that your device is on the right journey to US market clearance.
- Premarket notification submission (FDA 510(k))
- Premarket approval (PMA)
- De novo designations
- CLIA Waiver applications
- Breakthrough designation requests
- Emergency use authorizations
Qserve is dedicated to ensuring the success and continued growth of medical devices and IVDs in the US market. Our post-market services provide support to ensure your device is in compliance with regulatory requirements, as well as post-market trend analysis to monitor the ongoing success of your product.
- Quality management system internal and mock audits (FDA QSR/GMP, MDSAP, ISO 13485)
- Post-market monitoring and trend analysis/reporting
- Remediation (CAPA, recalls, inspections)
- Supplier audits
All medical devices must be listed with the FDA (Medical Device Listing) and all companies intending to market their medical devices in the US must notify the FDA of their intention and be registered (Establishment Registration), prior to the introduction of their products into the US market. Regardless of the product classification, Quality Systems Regulations (QSR) compliance is almost always required. Manufacturers located outside of the United States are required to appoint a US FDA Agent
to serve as their intermediary with the FDA. Qserve can serve as your US Agent ensuring a smooth route to FDA market clearance.
Need help with your market access regulatory strategy?
Qserve is your trusted partner for US market access.
Schedule a free introductory call